Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions
Karl Storz Endoscope nephroscopes (REF: 27840KA) are being recalled because their instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with a documentation and compliance issue. The device's instructions contain reprocessing modalities that lack FDA review and approval for safety and efficacy. The primarily procedural nature of the defect, combined with the Class II classification, supports a Moderate severity rating.
Plain-English summary
Karl Storz Endoscopy is recalling the Karl Storz Endoskope nephroscope (REF: 27840KA) distributed nationwide throughout the United States and U.S. territories. The device's instructions for use contain reprocessing modalities that have not been reviewed or approved by the FDA for safety and efficacy.
Proper reprocessing is critical for ensuring medical devices are safe and effective. Unapproved reprocessing instructions in the device documentation could result in inadequate sterilization or other safety concerns.
Affected customers should contact Karl Storz Endoscopy regarding approved reprocessing methods for this device.
The recalled product
- Product
- Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscope
- Hazard
- unapproved-reprocessing
- labeling-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/UDI: (01)04048551366660
Distribution
Distributed nationwide across the United States.
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